Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The UK's National Institute for Health and Care Excellence (NICE) has granted approval for Boehringer Ingelheim's dabigatran etexilate (Pradaxa) for use by the National Health Service to treat and prevent the recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
Subscribe to our email newsletter
In the UK, venous thrombosis or blood clotting is a major cause of death and for those patients that survive PE and DVT, there can be long term complications causing serious illness.
Compared with previously unaffected individuals, patients are 40-times more likely to suffer a further event after a first episode of DVT/PE.
Boehringer Ingeheim UK and Ireland medical director Charles de Wet said: "This news broadens the ways in which Pradaxa can be used allowing patients to have more choices.
"Our medicine is already accepted for use in England and Wales for the primary prevention of venous thromboembolism (VTE) after elective total hip or knee replacement surgery and for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation."
The positive NICE guidance is based on results from four phase III clinical trials involving more than 9,000 patients that showed the efficacy of Pradaxa 150mg twice daily in the treatment of DVT and PE and the prevention of recurrence compared to warfarin or placebo.
According to the company, Pradaxa has the longest clinical trial experience in patients with DVT/PE of any of the novel oral anticoagulants (NOACs).
Pradaxa is now offered to patients in England and Wales with DVT/PE, as well as their physicians, as a treatment option which does not require a dose adjustment during the standard course of treatment.